Quality Assurance Manager, Otometrics A/S

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Natus Medical Denmark A/SQuality Assurance Manager

Natus Medical Denmark A/S, Taastrup

As our Quality Assurance Manager, you will be responsible for the Natus Medical Denmark A/S Quality Management System based in Taastrup with multiple global locations.

Your duties and responsibilities will include:

  1. Ensure that all processes needed for the Quality Management System are established, implemented and maintained, including but not limited to: CAPA, complaint handling, design control, documentation control, internal audit, management review, nonconforming product, production and process controls, MDR, and field corrective actions.
  2. Responsible for maintaining quality system compliance with major Regulatory Authorities (U.S. FDA, Health Canada, Australian TGA, Brazilian ANVISA, Japan MHLW and PMDA, and the European Union). Stay up to date with current medical device regulations and identifies industry best practices.

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